Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): A phase 3, randomised-controlled, non-inferiority trial

The Lancet

Volumn 387, Issue 10020, 2016, Pages 760-769

  Maertens, Johan A ^a   Raad, Issam I ^b   Marr, Kieren A ^c,d   Patterson, Thomas F ^e   Kontoyiannis, Dimitrios P ^b   Cornely, Oliver A ^f   Bow, Eric J ^g,h   Rahav, Galia ⁱ   Neofytos, Dionysios ^d   Aoun, Mickael ^j   Baddley, John W ^k   Giladi, Michael ⁱ   Heinz, Werner J ^l   Herbrecht, Raoul ^m   Hope, William ⁿ   Karthaus, Meinolf ^o   Lee, Dong Gun ^p   Lortholary, Olivier ^q   Morrison, Vicki A ^r   Oren, Ilana ^s   Selleslag, Dominik ^t   Shoham, Shmuel ^c   Thompson, George R ^u   Lee, Misun ^v   Maher, Rochelle M ^v   Schmitt Hoffmann, Anne Hortense ^w   Zeiher, Bernhardt ^v   Ullmann, Andrew J ^x   more..

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d JOHNS HOPKINS UNIVERSITY   (United States)

^e UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^f UNIVERSITY OF COLOGNE   (Germany)

^g UNIVERSITY OF MANITOBA   (Canada)

^h CANCERCARE MANITOBA   (Canada)

ⁱ TEL AVIV UNIVERSITY   (Israel)

^j JULES BORDET INSTITUTE   (Belgium)

^k UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^l UNIVERSITY HOSPITAL WÜRZBURG   (Germany)

^m UNIVERSITY HOSPITAL OF STRASBOURG   (France)

ⁿ UNIVERSITY OF LIVERPOOL   (United Kingdom)

^o Klinikum Neuperlach   (Germany)

^p The Catholic University of Korea   (South Korea)

^q UNIVERSITÉ PARIS DESCARTES   (France)

^r UNIVERSITY OF MINNESOTA   (United States)

^s TECHNION ISRAEL INSTITUTE OF TECHNOLOGY   (Israel)

^t Dienst Pneumologie   (Belgium)

^u UNIVERSITY OF CALIFORNIA   (United States)

^v ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^w BASILEA PHARMACEUTICA INTERNATIONAL LTD   (Switzerland)

^x UNIVERSITY OF WÜRZBURG   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMPHOTERICIN B; ISAVUCONAZOLE; ISAVUCONAZONIUM; PLACEBO; VORICONAZOLE; ANTIFUNGAL AGENT; NITRILE; PYRIDINE DERIVATIVE; TRIAZOLE DERIVATIVE;

ABNORMAL LABORATORY RESULT; ADULT; AGITATION; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ANTIMICROBIAL THERAPY; ANTISOCIAL PERSONALITY DISORDER; ARTICLE; ASPERGILLUS; AUTOIMMUNE DISEASE; BENIGN TUMOR; BREAST DISEASE; CHOLESTASIS; COMPARATIVE EFFECTIVENESS; CONGENITAL DISORDER; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ERUPTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; EAR DISEASE; ENDOCRINE DISEASE; ERYTHEMA; EVIDENCE BASED PRACTICE; EYE DISEASE; FAMILIAL DISEASE; FEMALE; FEVER; FILAMENTOUS FUNGUS; GASTROINTESTINAL DISEASE; GENETIC DISORDER; GENITAL SYSTEM DISEASE; HALLUCINATION; HEART DISEASE; HEMATOLOGIC DISEASE; HEPATOBILIARY DISEASE; HUMAN; HYPERBILIRUBINEMIA; HYPOKALEMIA; IMMUNOPATHOLOGY; INFECTION; INFESTATION; INJURY; INNER EAR DISEASE; INTENTION TO TREAT ANALYSIS; INTOXICATION; INVASIVE ASPERGILLOSIS; JAUNDICE; KIDNEY DISEASE; LIVER DYSFUNCTION; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MEDIASTINUM DISEASE; MENTAL DISEASE; META ANALYSIS (TOPIC); METABOLIC DISORDER; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; NUTRITIONAL DISORDER; PHASE 3 CLINICAL TRIAL; PHOTOPHOBIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY TRACT DISEASE; RETINA HEMORRHAGE; SIDE EFFECT; SKIN DEFECT; SKIN DISEASE; THORAX DISEASE; TREATMENT OUTCOME; TREATMENT RESPONSE; URINARY TRACT DISEASE; UROGENITAL TRACT DISEASE; VASCULAR DISEASE; VISUAL ACUITY; VISUAL HALLUCINATION; VISUAL IMPAIRMENT; VOMITING; AGED; ASPERGILLOSIS; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; MYCOSES; ORAL DRUG ADMINISTRATION;

ADMINISTRATION, ORAL; ADULT; AGED; ANTIFUNGAL AGENTS; ASPERGILLOSIS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGED; MYCOSES; NITRILES; PYRIDINES; TREATMENT OUTCOME; TRIAZOLES; VORICONAZOLE;

EID: 84959108062     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(15)01159-9     Document Type: Article

References (32)

1. D Bitar, O Lortholary, Y Le Strat et al. Population-based analysis of invasive fungal infections, France, 2001-2010 Emerg Infect Dis 20 2014 1149 1155
2. O Lortholary, JP Gangneux, K Sitbon et al. Epidemiological trends in invasive aspergillosis in France: the SAIF network (2005-2007) Clin Microbiol Infect 17 2011 1882 1889
3. F Lanternier, O Lortholary Liposomal amphotericin B: what is its role in 2008? Clin Microbiol Infect 14 suppl 4 2008 71 83
4. DA Enoch, SF Idris, SH Aliyu, C Micallef, O Sule, JA Karas Micafungin for the treatment of invasive aspergillosis J Infect 68 2014 507 526
5. R Herbrecht, J Maertens, L Baila et al. Caspofungin first-line therapy for invasive aspergillosis in allogeneic hematopoietic stem cell transplant patients: an European Organisation for Research and Treatment of Cancer study Bone Marrow Transplant 45 2010 1227 1233
6. TJ Walsh, I Raad, TF Patterson et al. Treatment of invasive aspergillosis with posaconazole in patients who are refractory to or intolerant of conventional therapy: an externally controlled trial Clin Infect Dis 44 2007 2 12
7. TJ Walsh, EJ Anaissie, DW Denning et al. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America Clin Infect Dis 46 2008 327 360
8. J Maertens, O Marchetti, R Herbrecht et al. European guidelines for antifungal management in leukemia and hematopoietic stem cell transplant recipients: summary of the ECIL 3 - 2009 update Bone Marrow Transplant 46 2011 709 718
9. AM Tortorano, M Richardson, E Roilides et al. ESCMID and ECMM joint guidelines on diagnosis and management of hyalohyphomycosis: Fusarium spp., Scedosporium spp. and others Clin Microbiol Infect 20 suppl 3 2014 27 46
10. M Mikulska, A Novelli, F Aversa et al. Voriconazole in clinical practice J Chemother 24 2012 311 327
11. A Schmitt-Hoffmann, B Roos, M Heep et al. Single-ascending-dose pharmacokinetics and safety of the novel broad-spectrum antifungal triazole BAL4815 after intravenous infusions (50, 100, and 200 milligrams) and oral administrations (100, 200, and 400 milligrams) of its prodrug, BAL8557, in healthy volunteers Antimicrob Agents Chemother 50 2006 279 285
12. AJ Lepak, K Marchillo, J Vanhecker, DR Andes Isavuconazole (BAL4815) pharmacodynamic target determination in an in vivo murine model of invasive pulmonary aspergillosis against wild-type and cyp51 mutant isolates of Aspergillus fumigatus Antimicrob Agents Chemother 57 2013 6284 6289
13. G Luo, T Gebremariam, H Lee, JE Edwards Jr, L Kovanda, AS Ibrahim Isavuconazole therapy protects immunosuppressed mice from mucormycosis Antimicrob Agents Chemother 58 2014 2450 2453
14. AJ Lepak, K Marchillo, J VanHecker, D Diekema, DR Andes Isavuconazole pharmacodynamic target determination for Candida species in an in vivo murine disseminated candidiasis model Antimicrob Agents Chemother 57 2013 5642 5648
15. A Espinel-Ingroff, A Chowdhary, GM Gonzalez et al. Multicenter study of isavuconazole MIC distributions and epidemiological cutoff values for the Cryptococcus neoformans-Cryptococcus gattii species complex using the CLSI M27-A3 broth microdilution method Antimicrob Agents Chemother 59 2015 666 668
16. US Astellas Pharma Cresemba (isavuconazonium sulfate) prescribing information http://www.accessdata.fda.gov/drugsatfda-docs/label/2015/207500Orig1s000lbl.pdf 2015 (accessed Oct 10, 2015).
17. European Medicines Agency Cresemba (isavuconazole) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002734/human-med-001907.jsp&mid=WC0b01ac058001d124 2015 (accessed Dec 2, 2015).
18. B De Pauw, TJ Walsh, JP Donnelly et al. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group Clin Infect Dis 46 2008 1813 1821
19. US FDA Draft guidance on qualification of biomarker - galactomannan in studies of treatments of invasive aspergillosis http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM420248.pdf 2014 (accessed June 16, 2015).
20. DW Denning Therapeutic outcome in invasive aspergillosis Clin Infect Dis 23 1996 608 615
21. R Herbrecht, DW Denning, TF Patterson et al. Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis N Engl J Med 347 2002 408 415
22. B Spellberg, G Talbot Recommended design features of future clinical trials of antibacterial agents for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia Clin Infect Dis 51 suppl 1 2010 S150 S170
23. ER Ramos, Y Jiang, R Hachem, C Kassis, DP Kontoyiannis, I Raad Outcome analysis of invasive aspergillosis in hematologic malignancy and hematopoietic stem cell transplant patients: the role of novel antimold azoles Oncologist 16 2011 1049 1060
24. WB Park, NH Kim, KH Kim et al. The effect of therapeutic drug monitoring on safety and efficacy of voriconazole in invasive fungal infections: a randomized controlled trial Clin Infect Dis 55 2012 1080 1087
25. DR Falci, AC Pasqualotto Profile of isavuconazole and its potential in the treatment of severe invasive fungal infections Infect Drug Resist 6 2013 163 174
26. KA Marr, HT Schlamm, R Herbrecht et al. Combination antifungal therapy for invasive aspergillosis: a randomized trial Ann Intern Med 162 2015 81 89
27. JR Wingard, P Ribaud, HT Schlamm, R Herbrecht Changes in causes of death over time after treatment for invasive aspergillosis Cancer 112 2008 2309 2312
28. MH Miceli, J Maertens, K Buve et al. Immune reconstitution inflammatory syndrome in cancer patients with pulmonary aspergillosis recovering from neutropenia: proof of principle, description, and clinical and research implications Cancer 110 2007 112 120
29. BH Segal, R Herbrecht, DA Stevens et al. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria Clin Infect Dis 47 2008 674 683
30. OA Cornely, J Maertens, M Bresnik et al. Liposomal amphotericin B as initial therapy for invasive mold infection: a randomized trial comparing a high-loading dose regimen with standard dosing (AmBiLoad trial) Clin Infect Dis 44 2007 1289 1297
31. A Pascual, C Csajka, T Buclin et al. Challenging recommended oral and intravenous voriconazole doses for improved efficacy and safety: population pharmacokinetics-based analysis of adult patients with invasive fungal infections Clin Infect Dis 55 2012 381 390
32. K Tan, N Brayshaw, K Tomaszewski, P Troke, N Wood Investigation of the potential relationships between plasma voriconazole concentrations and visual adverse events or liver function test abnormalities J Clin Pharmacol 46 2006 235 243